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Efficacy of Consolidative Involved-site Radiotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma

NCT02449265 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-12-14

No results posted yet for this study

Summary

The most common option of radiotherapy for patients with limited-stage DLBCL is involved-field radiotherapy (IFRT). The more limited radiotherapy field size changing from IFRT to reasonable margin from gross tumor has been reported to maintain the high rates of local disease control, while minimizing the risks of radiation-induced toxicities. However, the research didn't analyze whether the efficacy of consolidation involved-site radiotherapy (ISRT) be affected by the response of chemotherapy. The biologic definition of clinical target volume (CTV) of ISRT and actual radiotherapy field size need to be ascertained.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

RADIATION

Consolidation involved-site radiotherapy (ISRT)

6 cycles modern CHOP chemotherapy. Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20\~25 fractions of 2 Gy 5 days per week for partial response (PR).

RADIATION

Consolidation involved-field radiotherapy (IFRT)

6 cycles modern CHOP chemotherapy. Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 15\~18 fractions of 2 Gy 5 days per week for partial response (PR).

DRUG

cyclophosphamide

Patients in both arms will be given cyclophpsphamide chemotherapy.

DRUG

doxorubicin

Patients in both arms will be given doxorubicin chemotherapy.

DRUG

vincristine

Patients in both arms will be given vincristine chemotherapy.

DRUG

prednisone

Patients in both arms will be given prednisone chemotherapy.

Sponsors & Collaborators

  • Wuhan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02449265 on ClinicalTrials.gov